Seasonal Allergic RhinitisPhase 1NCT01054352
A Single and Multiple Dose Study to Explore the Safety of JNJ-38224342 in Healthy Patients and Patients With Seasonal Allergies
A Phase 1 study testing JNJ38224342 in people with Seasonal Allergic Rhinitis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in Canada.
Trial summary
A single and multiple dose study to assess the safety of JNJ 38224342 compared to placebo in healthy volunteers and in volunteers with seasonal allergies. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- JNJ38224342
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2010to Mar 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smokers
- If male, willing to use an acceptable method of birth control for duration of study and for 90 days post study
- Females must be post menopausal, surgically sterilized and cannot be pregnant or lactating (all parts of study)
- Have a clinical history of allergic rhinitis during the ragweed pollen season and a positive skin test for ragweed allergy are required (for part 4 of study only)
Who cannot join
- Clinically significant medical illnesses, laboratory or ECG findings
- History of allergy to aspirin or nonsteroidal anti-inflammatory drugs
- history of alcohol or drug abuse within the last 5 years
- HIV or Hepatitis B or C positive
- Receipt of an investigational drug or use of an investigational medical device within the last month
- History of asthma or severe respiratory infection or disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Food Effect, and Pharmacokinetics and Pharmacodynamics of JNJ-38224342 in Healthy Patients and in Healthy Patients With Seasonal Allergic Rhinitis
A single and multiple dose study to assess the safety of JNJ 38224342 compared to placebo in healthy volunteers and in volunteers with seasonal allergies.
Read the detailed description
A four-part, single and multiple dose study to investigate the safety of JNJ-38224342 versus placebo in healthy patients and in patients with seasonal allergies. Volunteers (or patients) are randomly assigned to one of four treatment groups or Parts. Part 1 and 2 are randomized (study drug will be assigned by chance) and double-blind (neither the physician nor volunteer knows the identity of the assigned drug). In Part 1 patients receive a single oral dose of either 25, 100, 300, 600, 1250 or 2000 mg of JNJ-38224342 or placebo. In Part 2 patients receive multiple oral doses of either 100, 250, 500 or 700 mg of JNJ-38224342 or placebo administered over 14 days. Part 3 (for male volunteers only) is open-label (all people involved know the identity of the assigned drug), 2-period crossover (meaning that volunteers will receive both treatments at different times) study of the effects of food on JNJ-38224342. Participants will be given a single 100 mg oral dose (either solution or capsule formulation). Part 4 is for patients with seasonal allergies only. The dose of JNJ-38224342 will be determined based on information collected in Parts 1 - 3. Patients that participate in part 4 of the study will also have their nasal passage flushed out with salt water and the contents will be collected. Patients will be asked to remain in the clinic for either 5 days or 18 days depending on what part of the study they are participating in. A physical exam will be performed and a medical history collected. Safety evaluations include adverse event monitoring, blood pressure measurements, ECG and lab work requiring blood and urine samples at various time points throughout the study. Single oral dose of either 25, 100, 300, 600, 1250 or 2000mg of JNJ-38224342 or placebo; Multiple oral dose of either 100, 250, 500 or 700 mg of JNJ-38224342 or placebo administered over 14 days; single oral 100mg dose of JNJ 38224342 as a solution versus capsule with or without food; multiple oral doses of JNJ38224342 or placebo administered for up to 14 days where the number of days dosed, actual dose levels, food requirements will be determined based on the data from Parts 1, 2, and 3
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- JNJ38224342, JNJ38224342/placebo
- Keywords
- Seasonal allergies, Allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ38224342Drug
multiple ascending oral doses (100, 250, 500, 750 mg) of JNJ 38224342 or matching placebo, administered for 14 consecutive days in healthy male or female volunteers
JNJ38224342/placeboDrug
up to four (4) additional cohorts consisting of healthy male volunteers may be added
JNJ38224342/placeboDrug
.up to four (4) additional cohorts consisting of healthy male or female volunteers may be added
JNJ38224342/placeboDrug
one of six (6) single ascending doses (25, 100, 300, 600, 1250 or 2000 mg) of JNJ 38224342 or matching placebo
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | JNJ38224342/placebo one of six (6) single ascending doses (25 100 300 600 1250 or 2000 mg) of JNJ 38224342 or matching placebo up to four (4) additional cohorts consisting of healthy male volunteers may be added Receives: Drug: JNJ38224342/placebo |
| 002 | Experimental | JNJ38224342/placebo multiple ascending oral doses (100 250 500 750 mg) of JNJ 38224342 or matching placebo administered for 14 consecutive days in healthy male or female volunteers.up to four (4) additional cohorts consisting of healthy male or female volunteers may be added Receives: Drug: JNJ38224342/placebo |
| 003 | Experimental | JNJ38224342 single oral 100mg dose of JNJ 38224342 as a solution versus a single oral dose of JNJ 38224342 as a capsule formulation with and without food in healthy male volunteers Receives: Drug: JNJ38224342 |
| 004 | Experimental | JNJ38224342/placebo multiple oral doses of JNJ38224342 or matching placebo administered for up to 14 consecutive days in male and female volunteers number of days dosed and actual dose levels food requirements and regimens will be determined based on the data from Parts 1 2 and 3. Receives: Drug: JNJ38224342/placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess safety and pharmacokinetics of single and multiple oral ascending doses of JNJ-38224342 with and without food in healthy volunteers and patients with seasonal allergies as determined by occurrence of adverse events, lab test results, vital sign
Measured: from the time of the first dose to 7-11 days after the last dose administered
Secondary outcomes (2)
Evaluate the results of biomarker assessments performed during Parts 2 and 4 of the trial.
Measured: from 7-11 days post the last administered dose
Evaluate the effectiveness of treatment based on nasal symptoms for Part 4.
Measured: from 7-11 days post the last administered dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startFeb 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054352
- Sponsor's protocol ID
- CR016798
- Status last verified
- Sep 2013
- First submitted
- 21 Jan 2010
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Food Effect, and Pharmacokinetics and Pharmacodynamics of JNJ-38224342 in Healthy Patients and in Healthy Patients With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01054352
- Acronym / sponsor ID
- CR016798
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Seasonal allergies, Allergic rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Study completion
- Mar 2011 (actual)
- First posted
- 22 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single and multiple dose study to assess the safety of JNJ 38224342 compared to placebo in healthy volunteers and in volunteers with seasonal allergies.
Detailed description
A four-part, single and multiple dose study to investigate the safety of JNJ-38224342 versus placebo in healthy patients and in patients with seasonal allergies. Volunteers (or patients) are randomly assigned to one of four treatment groups or Parts. Part 1 and 2 are randomized (study drug will be assigned by chance) and double-blind (neither the physician nor volunteer knows the identity of the assigned drug). In Part 1 patients receive a single oral dose of either 25, 100, 300, 600, 1250 or 2000 mg of JNJ-38224342 or placebo. In Part 2 patients receive multiple oral doses of either 100, 250, 500 or 700 mg of JNJ-38224342 or placebo administered over 14 days. Part 3 (for male volunteers only) is open-label (all people involved know the identity of the assigned drug), 2-period crossover (meaning that volunteers will receive both treatments at different times) study of the effects of food on JNJ-38224342. Participants will be given a single 100 mg oral dose (either solution or capsule formulation). Part 4 is for patients with seasonal allergies only. The dose of JNJ-38224342 will be determined based on information collected in Parts 1 - 3. Patients that participate in part 4 of the study will also have their nasal passage flushed out with salt water and the contents will be collected. Patients will be asked to remain in the clinic for either 5 days or 18 days depending on what part of the study they are participating in. A physical exam will be performed and a medical history collected. Safety evaluations include adverse event monitoring, blood pressure measurements, ECG and lab work requiring blood and urine samples at various time points throughout the study. Single oral dose of either 25, 100, 300, 600, 1250 or 2000mg of JNJ-38224342 or placebo; Multiple oral dose of either 100, 250, 500 or 700 mg of JNJ-38224342 or placebo administered over 14 days; single oral 100mg dose of JNJ 38224342 as a solution versus capsule with or without food; multiple oral doses of JNJ38224342 or placebo administered for up to 14 days where the number of days dosed, actual dose levels, food requirements will be determined based on the data from Parts 1, 2, and 3
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: JNJ38224342/placeboJNJ38224342/placebo one of six (6) single ascending doses (25 100 300 600 1250 or 2000 mg) of JNJ 38224342 or matching placebo up to four (4) additional cohorts consisting of healthy male volunteers may be added |
| 002 | Experimental | Drug: JNJ38224342/placeboJNJ38224342/placebo multiple ascending oral doses (100 250 500 750 mg) of JNJ 38224342 or matching placebo administered for 14 consecutive days in healthy male or female volunteers.up to four (4) additional cohorts consisting of healthy male or female volunteers may be added |
| 003 | Experimental | Drug: JNJ38224342JNJ38224342 single oral 100mg dose of JNJ 38224342 as a solution versus a single oral dose of JNJ 38224342 as a capsule formulation with and without food in healthy male volunteers |
| 004 | Experimental | Drug: JNJ38224342/placeboJNJ38224342/placebo multiple oral doses of JNJ38224342 or matching placebo administered for up to 14 consecutive days in male and female volunteers number of days dosed and actual dose levels food requirements and regimens will be determined based on the data from Parts 1 2 and 3. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non-smokers
- If male, willing to use an acceptable method of birth control for duration of study and for 90 days post study
- Females must be post menopausal, surgically sterilized and cannot be pregnant or lactating (all parts of study)
- Have a clinical history of allergic rhinitis during the ragweed pollen season and a positive skin test for ragweed allergy are required (for part 4 of study only)
Key exclusion criteria (6 listed)
- Clinically significant medical illnesses, laboratory or ECG findings
- History of allergy to aspirin or nonsteroidal anti-inflammatory drugs
- history of alcohol or drug abuse within the last 5 years
- HIV or Hepatitis B or C positive
- Receipt of an investigational drug or use of an investigational medical device within the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ38224342multiple ascending oral doses (100, 250, 500, 750 mg) of JNJ 38224342 or matching placebo, administered for 14 consecutive days in healthy male or female volunteers | Drug | 003 |
| JNJ38224342/placeboup to four (4) additional cohorts consisting of healthy male volunteers may be added | Drug | 002 |
| JNJ38224342/placebo.up to four (4) additional cohorts consisting of healthy male or female volunteers may be added | Drug | 004 |
| JNJ38224342/placeboone of six (6) single ascending doses (25, 100, 300, 600, 1250 or 2000 mg) of JNJ 38224342 or matching placebo | Drug | 001 |
Primary outcome
To assess safety and pharmacokinetics of single and multiple oral ascending doses of JNJ-38224342 with and without food in healthy volunteers and patients with seasonal allergies as determined by occurrence of adverse events, lab test results, vital sign
Time frame: from the time of the first dose to 7-11 days after the last dose administered
2 secondary outcomes
Evaluate the results of biomarker assessments performed during Parts 2 and 4 of the trial.
Time frame: from 7-11 days post the last administered dose
Evaluate the effectiveness of treatment based on nasal symptoms for Part 4.
Time frame: from 7-11 days post the last administered dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ38224342 in people with Seasonal Allergic Rhinitis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess safety and pharmacokinetics of single and multiple oral ascending doses of JNJ-38224342 with and without food in healthy volunteers and patients with seasonal allergies as determined by occurrence of adverse events, lab test results, vital sign (time frame: from the time of the first dose to 7-11 days after the last dose administered). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2013; AzTrials last refreshed its copy on 28 Oct 2026.